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A Study to Evaluate the Efficacy and Safety of Frexalimab, Brivekimig, or Rilzabrutinib in Participants Aged 16 to 75 Years With Primary Focal Segmental Glomerulosclerosis or Minimal Change Disease

NCT06500702

RecruitingPhase 2

Sponsor: Sanofi

Conditions: Focal Segmental Glomerulosclerosis, Glomerulonephritis Minimal Lesion

Interventions: frexalimab, brivekimig, rilzabrutinib, placebo

Countries: United States, Argentina, Australia, Brazil, Canada, Chile, China, Czechia

This is a parallel, Phase 2a, double-blind, 6-arm study for the treatment of primary focal segmental glomerulosclerosis (FSGS) or minimal change disease (MCD). The purpose of this study is to measure the change in proteinuria and its impact on the rates of remission of nephrotic syndrome with frexalimab, brivekimig or rilzabrutinib compared with placebo in participants with primary FSGS or MCD aged 16 to 75 years. Study details for each participant include: The study duration will be up to 52 weeks. The treatment duration will be 24 weeks. There will be up to 16 visits.

Eligibility overview

Sex: ALL

Age: 16 Years to 75 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* Biopsy report indicative of primary FSGS or MCD, with supportive clinical presentation per Investigator's judgement.
* UPCR ≥3 g/g at screening, or ≥ 1.5 g/g in those with eGFR ≥ 60 mL/min/1.73 m2.
* eGFR ≥45 mL/min/1.73 m\^2 at screening.
* Documented history of UPCR or UACR (or 24-hour urine protein or 24-hour urine albumin) reduction by \>40% in response to corticosteroid or other immunosuppressive therapy when pre-treatment UPCR was ≥3.5 g/g or equivalent for UACR (or pre-treatment 24-hr urine protein was ≥3.5 g/day if 24-hour urine protein is used or equivalent for 24-hr urine albumin if 24-hour urine albumin is used).
* ≤10 mg/day prednisone or equivalent and stable starting at least 1 week prior to randomization.
* For those on a RAAS inhibitor prior to screening, the dose must be stable ≥4 weeks prior to screening; starting RAAS inhibitors or changing the dose will not be allowed during the double-blind or OLE treatment period.
* For those on an SGLT2 inhibitor prior to screening, the dose must be stable ≥4 weeks prior to screening; starting SGLT2 inhibitor treatment or changing the dose will not be allowed during the double-blind or OLE treatment periods.
* Body weight within 45 to 120 kg (inclusive) at screening.

Exclusion Criteria:

* Genetic or secondary FSGS or MCD. Those with APOL1 risk alleles are eligible.
* Collapsing variant of FSGS.
* ESKD requiring dialysis or transplantation.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Locations (71)

Birmingham, Alabama, United States
Orange, California, United States
San Francisco, California, United States
Tampa, Florida, United States
Atlanta, Georgia, United States
Chicago, Illinois, United States
Hinsdale, Illinois, United States
Ann Arbor, Michigan, United States
Edina, Minnesota, United States
Las Vegas, Nevada, United States
Albuquerque, New Mexico, United States
New York, New York, United States
Chapel Hill, North Carolina, United States
Dallas, Texas, United States
El Paso, Texas, United States
Houston, Texas, United States
Buenos Aires, Argentina
Córdoba, Argentina
Garran, Australian Capital Territory, Australia
Parkville, Victoria, Australia
Botucatu, São Paulo, Brazil
São Paulo, São Paulo, Brazil
São Paulo, Brazil
São Paulo, Brazil
London, Ontario, Canada
Montreal, Quebec, Canada
Montreal, Quebec, Canada
Québec, Quebec, Canada
Temuco, La Araucanía, Chile
Santiago, Reg Metropolitana de Santiago, Chile
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